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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004704-34 | EudraCT Number |
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The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).
An increasing percentage of elderly patients with localized prostate cancer undergo RALP, due to the higher safety and feasibility of this minimally invasive surgical option compared to standard open procedure. This procedure is performed under deep neuromuscular block (dNMB) in order to guarantee an adequate working space. Induction and maintenance of the dNMB require neuromuscular monitoring and adequate reversal at the end of the intervention to prevent postoperative residual curarization (PORC). Sugammadex is the most attractive strategy to titrate reversal according to NMB monitoring data and to ensure a complete recovery of muscle function before extubation. In elderly patients, the risk of PORC and related postoperative complications is higher. For these reasons, we hypothesize that a dose of sugammadex increased by 50% compared to a standard dose could significantly shorten neuromuscular recovery time, extubation time, OR discharge time and PACU length of stay in elderly patients undergoing RALP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Increased dose of sugammadex | Experimental | A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery |
|
| Standard dose of sugammadex | Active Comparator | A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex 6 mg/kg | Drug | i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuromuscular recovery time | Time from the end of sugammadex administration to train-of-four (TOF)=1 | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation | Time from neuromuscular reversal (TOF=1) to extubation | 10 minutes |
| Time to OR exit | Time from neuromuscular reversal (TOF=1) to exit from the operating room |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paola Aceto, MD, PhD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome | 00168 | Italy |
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The patient as well as the investigator (care provider) who will administer the different blinded sugammadex dosage and collect postoperative data will be blinded to the group allocation. The randomization and preparation of the drug will be performed by the unblinded staff of hospital experimental pharmacy who will carry out the randomization with a 1: 1 ratio and will assign the different dose to each patient. The drug will be prepared in a shielded pre-filled syringe in order to maintain blindness. In case of emergency, the pharmacy staff will immediately open the randomization code of interest disclosing the group assignment (sugammadex dose).
| Sugammadex 4 mg/kg | Drug | i.v. injection of a standard dose of sugammadex to reverse dNMB |
|
|
| 30 minutes |
| PACU length of stay | Duration of stay in the post-anaesthesia care unit | 2 hours |
| Hemodynamic parameters | Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration | up to discharge from post-anaesthesia care unit, an average of 2 hours |
| Respiratory function | Peripheral oxygen saturation (percentage) and respiratory rate (breaths per minute) after sugammadex administration | up to discarge from post-anaesthesia care unit, an average of 2 hours |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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